Table 1.
Change from baseline in EQ-5D utility scores at week 16, with censoring after rescue treatment and last-observation-carried-forward for imputation of missing data (full analysis set)
| Placebo qw, n = 460 | Dupilumab 300 mg qw, n = 462 | Dupilumab 300 mg q2w, n = 457 | |
|---|---|---|---|
| All patients | |||
| Baseline, mean (SD) | 0.611 (0.340) | 0.607 (0.338) | 0.629 (0.319) |
| LS mean change (SE) | 0.031 (0.012) | 0.207 (0.012) | 0.210 (0.012) |
| P vs. placeboa | – | <0.0001 | <0.0001 |
| Respondersb | |||
| IGA, n (%) | 43 (9.3) | 169 (36.6)c | 170 (37.2)c |
| Baseline, mean (SD) | 0.746 (0.33) | 0.664 (0.30) | 0.668 (0.30) |
| LS mean change (SE) | 0.192 (0.02) | 0.261 (0.01) | 0.238 (0.01) |
| P vs. placeboa | – | 0.2951 | 0.8232 |
| EASI ≥50%, n (%) | 107 (23.3) | 282 (61.0)c | 306 (67.0)c |
| Baseline, mean (SD) | 0.693 (0.334) | 0.636 (0.314) | 0.627 (0.325) |
| LS mean change (SE) | 0.189 (0.016) | 0.255 (0.010) | 0.253 (0.010) |
| P vs. placeboa | – | 0.0003 | 0.0004 |
| EASI ≥75%, n (%) | 61 (13.3) | 232 (50.2)c | 218 (47.7)c |
| Baseline, mean (SD) | 0.712 (0.347) | 0.629 (0.314) | 0.631 (0.327) |
| LS mean change (SE) | 0.251 (0.020) | 0.262 (0.010) | 0.257 (0.011) |
| P vs. placeboa | – | 0.6089 | 0.7825 |
EASI Eczema Area and Severity Index, EQ-5D 5-dimension 3-level EuroQol, IGA Investigator’s Global Assessment, LS least squares, qw once weekly, q2w every 2 weeks
aTreatments were compared using analysis of covariance with baseline as covariate and treatment, region, and baseline IGA strata as fixed factors; a study identifier was included as an additional factor for the pooled analysis
bResponders were defined as patients who achieved at week 16 an IGA score of 0 or 1 (clear or almost clear) and a reduction from baseline ≥2 points; and improvements ≥50% and ≥75% in the EASI
c P < 0.001 vs. placebo for proportion of responders